CTD Section 1.9.1 Report
Summary
Section Name:
Request for waiver of pediatric studies
Section Code:
1.9.1
Module Number:
1
Description:
Request by Sponsor for FDA to waive pediatric study requirement under PREA
Submission Timing
Any submission prior to marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources